TROSPIUM CHLORIDE capsule, extended release

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

TROSPIUM CHLORIDE (UNII: 1E6682427E) (TROSPIUM - UNII:T4Y8ORK057)

Sẵn có từ:

Golden State Medical Supply, Inc.

INN (Tên quốc tế):

TROSPIUM CHLORIDE

Thành phần:

TROSPIUM CHLORIDE 60 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Trospium chloride extended-release capsules are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Trospium chloride extended-release capsules are contraindicated in patients with: - urinary retention - gastric retention - uncontrolled narrow-angle glaucoma - known hypersensitivity to the drug or its ingredients. Angioedema, rash and anaphylactic reaction have been reported. Teratogenic Effects Pregnancy Category C : There are no adequate and well-controlled studies of trospium chloride extended-release capsules in pregnant women.  Trospium chloride extended-release capsules should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus. Women who become pregnant during trospium chloride extended-release capsules treatment are encouraged to contact their physician. Trospium chloride was not teratogenic at statistically significant levels in rats

Tóm tắt sản phẩm:

Trospium chloride extended-release capsules are supplied as 60 mg capsules (orange cap printed with “WPI” and white opaque body printed with “3636” ): 60 mg capsule, 30 count, HDPE bottle: NDC 60429-098-30 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

TROSPIUM CHLORIDE- TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE
GOLDEN STATE MEDICAL SUPPLY, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
TROSPIUM CHLORIDE EXTENDED-RELEASE CAPSULES
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TROSPIUM CHLORIDE EXTENDED-RELEASE
CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
TROSPIUM CHLORIDE EXTENDED-RELEASE
CAPSULES.
TROSPIUM CHLORIDE EXTENDED-RELEASE CAPSULES
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
Trospium Chloride Extended-release Capsules are a muscarinic
antagonist indicated for the treatment of overactive
bladder (OAB) with symptoms of urge urinary incontinence, urgency, and
urinary frequency. ( 1)
DOSAGE AND ADMINISTRATION
The recommended dosage of Trospium Chloride Extended-release Capsules
is one 60 mg capsule daily in the
morning. Trospium Chloride Extended-release Capsules should be dosed
with water on an empty stomach, at least one
hour before a meal. ( 2)
Trospium Chloride Extended-release Capsules are not recommended for
use in patients with severe renal impairment
(creatinine clearance less than 30 mL/minute). ( 2)
DOSAGE FORMS AND STRENGTHS
1. 60 mg capsules ( 3)
CONTRAINDICATIONS
Trospium Chloride Extended-release Capsules are contraindicated in
patients with urinary retention, gastric retention, or uncontrolled
narrow-angle glaucoma, and in patients who are at risk
for these conditions ( 4)
patients with known hypersensitivity ( 4)
WARNINGS AND PRECAUTIONS
Trospium Chloride Extended-release Capsules should be administered
with caution to patients with clinically significant
bladder outflow obstruction or gastrointestinal obstructive disorders
due to risk of urinary or gastric retention. ( 5.1, 5.3)
Angioedema of the face, lips, tongue and/or larynx has been reported
with trospium chloride ( 5.2)
In patients with narrow angle glaucoma, Trospium Chloride
Extended-release Capsules should be used only with
careful monitoring. ( 5.4)
Central Nervous System Effects: Somnolence has been reported with
Trospi